BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SANDHILL SCIENTIFIC

    MDR report key: 9928136 · Received April 6, 2020

    Report

    Report Number
    9928136
    Event Type
    Malfunction
    Date Received
    April 6, 2020
    Date of Event
    February 11, 2020
    Report Date
    March 27, 2020
    Manufacturer
    DIVERSATEK HEALTHCARE, INC.
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SANDHILL MANOMETRY EQUIPMENT UNABLE TO CALIBRATE CATHETER PRIOR TO PROCEDURE. CLINICAL ENGINEERING TECH IN UNIT AND TROUBLE SHOOTING. SANDHILL REPRESENTATIVE CALLED AND UNABLE TO ASSIST WITH REPAIR. SANDHILL TECHNICAL SUPPORT CALLED AND HAD TO LEAVE MESSAGE BECAUSE CALL CENTER IS IN (B)(6). PATIENT WAS UNFORTUNATELY ALREADY PRESENT AT FACILITY, SO I SPOKE WITH HIM AND EXPLAINED SITUATION. HE AND WIFE WERE VERY UNDERSTANDING. WAITING TO HEAR FROM SANDHILL AND CLINICAL ENGINEERING FOR NEXT STEP IN TROUBLE SHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391491 SANDHILL SCIENTIFIC SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX DIVERSATEK HEALTHCARE, INC. DPQTQG2

    Patients

    Seq Age Sex Outcome Treatment
    1